Proneb Ultra

GUDID 00744229100393

Replacement Filter, WG bulk

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable
Primary Device ID00744229100393
NIH Device Record Keyeca9089e-4ee1-4c67-bd03-063bff984b46
Commercial Distribution StatusIn Commercial Distribution
Brand NameProneb Ultra
Version Model Number041F4852WG
Company DUNS804736098
Company NamePARI RESPIRATORY EQUIPMENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100744229100393 [Package]
Contains: 00744229410874
Package: carton [12 Units]
In Commercial Distribution
GS100744229410874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-17

On-Brand Devices [Proneb Ultra]

00744229850342Replacement Filter Set, Ultra
00744229850359Filter Set, Ultra
00744229100379Replacement Filter
00744229100393Replacement Filter, WG bulk
00744229100386Replacement Filter, WG
00744229100317Filter, Air

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